USPTO Patents Application 10551504

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H PATENT COOPERATION TREATY

PCT

INTERNATIONAL PRELIMINARY REPORT ON PATENTABILITY

(Chapter II of the Patent Cooperation Treaty)

IPCT Article 36 and Rule 70)

Applicant's or agent's file reference

C1-A0323P

FOR FURTHER ACTION

SeeForroPCT/IPEA/416

International application No.

PCT/JP2004/018501

International Tiling date tdaWmotuh/year)

10.12.2004

Priority date (day/monih/year)

12.12.2003

International Paten! Classification (IPC) or national classification and IPC

C07K16/28, C12N16/00, C12N1/15, C12N1/19, C12N1/21, C12N5/00,
C12P21/02, A61K98/395, A61P35/00, A61P35/02, A61P37/02,

Applicant

CHUGAI SEIYAKU KABUSHIKI KAISHA

2.
3.

This report is the international preliminary examination report, established by this International Preliminary Examining Authority
under Article 35 and transmitted to the applicant according to Article 36.

TWj REPORT consists of a total of _J_ sheets, including this cover sheet.

This report is also accompanied by ANNEXES, comprising:

(sen! to the applicant and to the International Bureau) a total of

sheets, as follows:

□
□

sheets of the description, claims and/or drawings which have been amended and are the basis for this report and/or
sheets containing rectifications authorized by this Authority (see Rule 70.16 and Section 607 of the Administrative
Instructions).

sheets which supersede earlier sheets, bat which this Authority considers contain an amendment that goes beyond
the disclosure in the international application as filed, as indicated in item 4 of Box No. I and the Supplemental
Box.

□

(sent to the Internatioiml Bureau only) a total of (indicate type and number of electronic carrier(s)>

. containing a sequence listing and/or tables
related (hereto, in computer readable form only, as indicated in the Supplemental Box Relating to Sequence Listing (see
Section 802 of (he Administrative Instructions).

This report contains indications relating to the following items:
Basis of the report
Priority

Non-establishment of opinion wttb regard to novelty, inventive step and industrial applicability
Lock of unity of invention

Reasoned statement under Article 35(2) with regard to novelty, inventive step or industrial applicability:
citations and explanations supporting such statement

Certain documents cited

Certain defects in the international application

Certain observations on the international application

IS

Box No. I

□

Box No. n

□

Box No. ID

□

Box No. IV

El

Box No. V

□

Box No. VI

□

Box No. VII

□

Box No. VD1

Date of submission of the demand

Date of completion of this report

Name and mailing address of the IPEA/JP
Facsimile No.

Authorized officer
Telephone No.

Form PCTVI PEA/409 (cover sheet) (January 2004)

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INTERNATIONAL PRELIMINARY REPORT ON PATENTABILITY

lilcmaiional application No.

PCT/JP2004/018501

Box No. I

Basis of the report

1. With regard to the language, this report i: based on the international application in the language in which it was filed, unless otherwise
indicated under this item.

T~~l This report is based on translations from the original language into the following

— which it the language of a translation furnished for the purposes of: "
international search (Rule 123 and 23.1(b»
I I publication of the international application (Rule 12.4)
CD international preliminary examination (Rule J5.2 and/or 55.?)

2. With regard to the dements of the international application, this report is based on (replacement sherts itn/rA haw tern furnished to the
receiving Office in response to an invitation under Article N are referred In in this report at "originally filed" and are not annexed to
this report):

□

the international application as originally filed/furnished
the description:

pages ________________________

ft"' .

pages*

as originally filed/furnished

□

received by this Authority on
received by this Authority on

the claims:

nos.

nos.* __
nos.* ___
no*.*

as originally filed/furnished

as amended (together with any statement) under Article 19

□

received by this Authority on
received by this Authority on

the drawings:

sheets

sheets'

sheets*

as originally fllecVfurnished

received by (his Authority oo
received by this Authority on

□ a sequence listing and/or any related taUe<s) - see Supplemental Box Relating to Sequence Listing.
CD The amendments have resulted in the cancellation of:

□ the description, pages
CD the claims, nos.

□ the drawings, sheets/figi

I 1 the sequence listing (specify):

any table(i> related to sequence listing (specify). _________________

| I This report has been established as if (some of) the amendincnti annexed to this report and listed below had not been made, since
1 — 1 they have been considered to go beyond the disclosure as filed, as indicated in the Supplemental Box (Rule 70.2(c)).

□ the description, pages

I I the claims, nos.

□ •he drawings, shecta/figs

I I the sequence listing (specify):

any table(i) related to sequence lining (specify):

If item V applies, some or all of those sheets mm be marked 'superseded. "

Form PCT7IPEA/409 (Box No. 1) (January 2004)

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INTERNATIONAL PRELIMINARY REPORT ON PATENTABILITY

International application No.

PCT/JP2004/018501

Box No. V Reasoned stBlemenl under Aril tie 35(2) with regard to novelty, inventive step or industrial applicability;
citations and explanations supporting such statement

1. Statement

Novelty (N)

Claims

1-28

YES

Claims

NO

Inventive Sep (IS)

Clainu

15

YES

Claims

1-14, 16-28

NO

Industrial applicability (IA)

Claims

1-28

YES

Claims

NO

2. Citations and explanations (Rule 70.7)

Documents 1 to 6 below were cited in the international
search report:

Document 1: Sekimoto E. et al., Blood, November 2003,

Vol. 102, No. 11, page 933a, Abstract, #3474
Document 2: Kipriyanov, S.M. et al., J. Mol . Biol., June

2003, Vol. 330, No. 1, pages 99 to 111
Document 3: Laurent Genestier et al., Blood, 1997, Vol.

90, No. 9, pages 3629 to 3639
Document 4: Hudson P.J. et al., J. Immunol. Methods,

1999, Vol. 231, No. 1-2, pages 177 to 189.

Review

Document 5: JP 7-503622 A (The Dow Chemical Company), 20
April 1995, entire description

Document 6: CO M.S. et al., J. Immunol., 1994, Vol. 152,
No. 6, pages 2968 to 2976

Document 1 sets forth a monoclonal antibody (2D7),
and indicates that said monoclonal antibody recognizes
HLA class I HLA-A.

Document 2 sets forth a bispecific scFV antibody
containing two variable heavy chain domains and two
variable light chain domains (see fig. 1, etc.).

Document 3 sets forth MoAb90 and YTH862, which are

Form PCTflPEA/409 (Box No. V) (January 2004)

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International application No.

INTERNATIONAL PRELIMINARY REPORT ON PATENTABILITY

PCT/JP2004/018501

Box No. V Reasoned statement under Article 35(2) with regard to novelty, Inventive step or Industrial applicability;

citations and explanations supporting such statement

monoclonal antibodies for human HLA class

IA.

Documents 4 and 5 both disclose sc(Fv)2.

Document 6 sets forth a method of obtaining DNA
which codes monoclonal antibodies.

The invention set forth in claims 1 to 28 involves
an inventive step in relation to documents 1 to 6.

The invention set forth in claims 1 to 28 of this
application is not disclosed in documents 1 to 6.

The invention set forth in claims 1 to 14 and 16 to
28 does not involve an inventive step in the light of a
combination of documents 1, 2 and 6.

It would be easy for a person skilled in the art to
use the method set forth in document 6 to obtain the DNA
which codes a monoclonal antibody (2D7) set forth in
document 1, and to prepare a bispecific scFv antibody of
the monoclonal antibody (2D7) using the method for
preparing a bispecific scFv set forth in document 2 from
the DNA thus obtained.

The invention set forth in claim 1 to 7 and 17 to 28
does not involve an inventive step in the light of a
combination of documents 3 to 6. It would be easy for a
person skilled in the art to conceive of using the method
set forth in document 6 to obtain DNA which codes the
monoclonal antibodies MoAb90 and YTH862 set forth in
document 3, and to prepare the sc(Fv)2 of the monoclonal
antibodies MoAb90 and YTH862 using the methods of
preparing sc(Fv)2 set forth in documents 4 and 5 from the
DNA thus obtained.

i

Form PCT/1PEA/409 (Box No. V) (January 2004)

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INTERNATIONAL PRELIMINARY REPORT ON PATENTABILITY

International application No.

PCT/JP2004/018501

Box No. V Reasoned statement under Article 35(2) with regard lo novelty, inventive step or Industrial applicability;

dtallontand explanations supporting such statement

The invention set forth in claim 15 involves an
inventive step in relation to documents 1 to 6.

The sc(Fv)2 having the amino acid sequence set forth
in SEQ ID NO: 2 described in claim 15 is an sc(Fv)2 of a
monoclonal antibody (2D7), but said sc(FV)2, as set forth
in fig. 4 and 5, has the same activity as 2D7DB which is
a diabody of the monoclonal antibody (2D7), and as shown
in fig. 6, markedly improves the stability in the blood,
and a person skilled in the art would not be able to
predict this feature.

Form PCT/IPE A/409 (Box No. V) (January 2004)

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INTERNATIONAL PRELIMINARY REPORT ON PATENTABILITY

International application No.

PCT/JP2004/018501

Supplemental Box Relating to Sequence Listing

Continuation of Box No. I, item 2:

I. With regard to any nucleotide and/or amino acid sequence disclosed In the Internallonal application and necessary to the claimed invention,
this report was established on (he basis of:

a. type of material
1^3 a sequence listing
D tablets) related lo the sequence listing

b. formal of material
I— I in written formal
13 in c ompul er readable form

e. lime of filing/furnishing

1X1 contained in the international application as filed
□ filed together with the international application in computer readable form
I— J furnished subsequently to this Authority far the purposes of search and/or examination
I | received by this Authority as an amendment* on

2. In addition, in the case that more than one version or copy of a sequence listing and/or tablets) relating thereto has been filed or

furnished, the required statements that the information in the subsequent or additional copies is identical to that in the application as
filed or does not go beyond the application as filed, as appropriate, were furnished

3. Additional comments:

• If item -I in Box No. I applies, the listing and/or table(s) related thereto, which form part of the basis of the report may be marked
"superseded. "

Form PCT/IPEAM09 (Supplemental Box Relating lo Sequence Listing) (January 2004}

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INTERNATIONAL PRELIMINARY REPORT ON PATENTABILITY

International application No.

PCT/JP2004/018501

Supplemental Box

In rase Ihe space in any of (he preceding boxes Is not sufficient.
Continuation of:

(IPC) Int. CI. 7

A61P13/00, C12P21/08

Form PdYIPEA/40° (Supplemental Box) (January 20O4)